Randomised trial comparing a Low Carbohydrate Diet and a Low Glycaemic Index Diet on body weight, hyperandrogenism and cardiovascular risk factors in women with Polycystic Ovary Syndrome (PCOS)
| ISRCTN | ISRCTN55425758 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55425758 |
| Protocol serial number | N0199129935 |
| Sponsor | Department of Health |
| Funder | Royal Berkshire and Battle Hospitals NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 06/04/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Mohgah Elsheikh
Scientific
Scientific
Centre for Diabetes & Endocrinology
Melrose House
Royal Berkshire Hospital
London Road
Reading
RG1 5AN
United Kingdom
| Phone | +44 (0)118 987 7131 |
|---|---|
| mohgah.elsheikh@rbbh-tr.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised case-controlled prospective study |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Does a low carbohydrate high protein diet enhance weight loss and improve symptoms in women with polycystic ovary syndrome (PCOS)? Assessment of the effects of the low carbohydrate diet on serum androgens and cardiovascular risk factors such as insulin sensitivity and plasma lipids. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Nutritional, Metabolic, Endocrine: Polycystic ovarian syndrome (PCOS) |
| Intervention | Low Carbohydrate Diet vs Low Glycaemic Index Diet |
| Intervention type | Other |
| Primary outcome measure(s) |
Weight, body composition, dietary compliance, menstrual cyclicity, ovulation, fasting glucose, insulin and lipids, hirsutism and serum androgens |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | Female |
| Target sample size at registration | 60 |
| Key inclusion criteria | 60 women with PCOS aged 18-45 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 30/07/2003 |
| Date of final enrolment | 30/04/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Centre for Diabetes & Endocrinology
Reading
RG1 5AN
United Kingdom
RG1 5AN
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | results published | No | No |
